Re: Food Supplements

Dear member of the European Parliament,

La Leva di Archimede is an association of consumers concerned with the freedom of choice of the individual in matters of health. This includes the choice of alternative methods of health care as well as the freedom to use nutritional substances such as vitamins, minerals, fatty acids and various vegetable extracts as well as herbs for the purpose of achieving and maintaining optimal health. We are located in Italy and are collaborating with various associations and individuals in other countries, working to achieve this aim.

The European Commission has proposed a directive on the subject of food supplements, which is to be discussed and voted on in Parliament during the coming week.

The current text of the directive is ambiguous and will eventually lead to a removal from the market of a large number of products in existence today, limiting freedom of choice of consumers and limiting as well the efficacy of supplements for public health.

There are two ways in which the directive will limit the access to supplements; one is an exclusive, socalled "positive" list of allowed ingredients found in the annex, and the other is a limiting of dosages based on a procedure (toxicological evaluation) that is not compatible with the products to be evaluated.

"Positive" list

This is an exclusive list of nutrient sources introduced as an annex to the proposed directive and referred to in article 4. 1, which states: "Only the vitamins and minerals listed in Annex 1 and the vitamin formulations and the permitted salts of the mineral substances listed in Annex 2 may be used for the manufacture of food supplements."

This will leave "out in the cold", and therefore "verboten" many of the currently used mineral formulations and some vitamins, not to speak of other substances, affecting a large part of today's range of health products. For a list of substances that have been "forgotten" to be included in the annexes, see

Article 4. 3 states that modifications to the annexes "shall be adopted under the procedure laid down in Article 13".

The procedure for adding substances to the Annex is referred to in Article 13 in a fairly obscure way. In fact, in Article 13 we read that "the regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Article 7 (3) and Article 8 thereof".

In simple words, the procedure referred to is a complicated and extremely costly one, whereby, in order to add any substance to the annex, a submission has to be made, proving scientifically and beyond any shadow of doubt through clinical and toxicological trials that the substance has been fully assessed as to it's lethal dose, it's pharmacokinetics, it's metabolic fate in the body and so on. In addition to being extremely costly and time consuming, such a requirement implies the useless suffering and death of thousands upon thousands of laboratory animals, sacrificed because of a senseless and cruel procedure that some call "scientific", being applied to what in essence are food ingredients.

Once the "scientific dossier" has been submitted, the SCF deliberates behind closed doors, and on it's verdict depends whether a substance may then be used in the manufacture of food supplements.

In fact the substances already approved (those contained in an equivalent list made under the directive covering foods for a particular nutrition - in this case baby foods) are those substances that have historically been used as ingredients in pharmaceutical medicines and thus had already been "researched" in the way described above. Most of the more recently developed substances have not been used in medicines and the manufacturers either will have to face a heavy burden of investment (unlikely because the substances are not patentable) in the range of hundreds of thousands of euros for every single substance, or the substances will vanish from the market.

Another alternative, perhaps even more serious, is for these substances to be "forced underground", that is, forced to form a new "black market" or a "grey zone" of products that are in demand by consumers but the existence of which is not acknowledged by the authorities. This has very serious implications for the freedom of choice of consumers and may even as much as defeat the very purpose for which a directive has been proposed. If consumers have to turn to a "grey market" as the only way of obtaining the health products of their choice, would we not be better off without a directive altogether?

Dosage limits

Also the determination of "allowed maximum dosages" is left to an obscure procedure, to be activated only after the passage of the directive into law. We read in Article 5, that such maximum amounts of vitamins and minerals are to be set after taking into account "upper safe levels established by scientific risk assessment" as well as "reference intakes for the population", better known as RDAs, the minimum levels needed to avoid the most serious deficiency diseases.

In any case, those maximum amounts are to be adopted (Article 5. 3) "in accordance with the procedure laid down in Article 13". Here again, article 13 refers us to a text that is not part of the directive. The translation into common language is more or less the following: The SCF will recommend what it believes to be "upper safe levels", based on a review of the medical literature and on the application of "toxicological parameters" to the data. In some cases, the SCF will state that an upper safe level cannot be recommended, because data are insufficient and in some cases the SCF will state that it sees no purpose in recommending an upper safe level as there is no scientific rationale for supplementation with levels higher than the RDA. Such decisions have already been published and can be consulted on the internet. Addresses available on request.

Upon the recommendations or the non recommendations as the case may be, of the SCF, and after taking into account "other factors" that the Commission is declining to quantify at this time, the Commission will then decide what should be the minimum and the maximum limits of nutrients in food supplements. These decisions lack a transparent procedure and are apt to be highly arbitrary.

Apart from a lack of transparency of the procedure, there is a problem with the application of "risk analysis" and "risk management" to nutrients. Risk analysis in fact has been developed as part of toxicological procedures for the purpose of managing toxic chemical substances and disease causing organisms in the environment. The basic assumption is that these substances have no use and no place in the food chain. For nutrients, this basic premise is not true, their presence in the food chain is of vital importance. In fact, toxicological methods are incompatible for the evaluation of nutrients. Thus, again, the procedure proposed by the Commission has serious implications for consumer choice, threatening to remove from the market a great number of products available today.

Many consumers are very concerned about these developments and are expressing their concern through a petition which they signed, which can be consulted at the web site of La Leva di Archimede, at

More than 13.000 persons from all over the world and from all walks of life have signed the petition since it was made available two months ago. The petition asks regulators to take consumer choice into account when discussing legislation concerning supplements.

Why regulate?

What would be the purpose of regulating the production and distribution of food supplements in a draconian way?

For one, supplements have proven, by actual statistics, to be an extremely safe category of products, even in those countries where they are regularly used by a large part of the population. A graphical representation of the relative risk of dying from the consumption of supplements versus other causes of death is available at the site of La Leva di Archimede at:

This graphic forms part of an article evaluating the safety of dietary supplements at:

The compilation and evaluation of statistical data prepared by Ron Law, executive director of the National Nutritional Foods Association of New Zealand, shows not only the extreme safety of food supplements as available on the market today, it also provides a succinct insight into the danger posed by pharmaceutical medicines which are "scientifically evaluated and properly registered, prescribed and taken according to instructions", which have become the fourth leading cause of death just after cancer and smoking.

We should seriously ask ourselves whether the methods of scientific control applied to medicines, in the light of these facts, would do anything at all to further improve the safety of supplements if applied to them.

But even assuming this would be the case and the safety of supplements could be significantly improved over current levels, what would be the social cost of such an operation?

We believe that the positive health effects of supplements, which depend in no small measure on the ability of the (mostly small and medium sized) producers to respond to changes in scientific understanding and to technological developments, would be seriously blunted by the effects of the directive if implemented in it's present form.

Cui prodest?

Cui prodest - "who stands to benefit from this?" - is the question we must ask in the face of such an overwhelming number of completely illogical and contradicting "solutions" we find in the directive.

The answer is, that the only ones to profit from putting food supplements "into a pharmaceutical straitjacket" are the pharmaceutical multinationals. The directive will afford them what often is termed euphemistically a "level playing field" - translation: a market where only the pharmaceutical multinationals are able to compete (with each other).

As a direct result of the implementation of the directive, market control will pass to the pharmaceutical multinationals because

- pharmaceutical companies will be the only ones able to sustain the costs of adding substances to the lists in the annex;

- pharmaceutical companies will be having complete control over whether to "allow a substance on the supplements market" or whether to incorporate it into proprietary medicinal products;

- through the application of an incompatible method of "scientific evaluation" of the risks allegedly connected with supplements, dosages for products on the free market will be limited, allowing pharmaceutical companies to keep the more lucrative part of the market to themselves, supplying such products as "registered medicines"..

This will lead to increased prices, because pharmaceutical companies will be able to control the prices of products thanks to the elimination of competition by today's small and medium sized companies.

For consumers, the consequences will be a marked reduction of their freedom of choice in matters of health and prevention, and an increased cost of nutritional products, as compared to the present situation.

It is also feared that public health may be adversely affected because prevention strategies will suffer a serious blow from the greatly diminished choice of safe and efficacious nutritional products,.

For these reasons, we ask you not to support the directive in it's present form and until such time that a text is worked out which does not have such potentially disastrous social consequences.

La Leva di Archimede